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Drug · FAERS side-effect profile with label screen

Ziprasidone side effects: what 3,553 FDA adverse event reports show

Ziprasidone · 1,090 reaction terms · 70,527 drug–reaction co-reports · data 2026-09-14
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Drug class

Not stated in label

Who reports

3,553 reports · 83% serious · 569 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding.

FDA label, Indications and Usage

What it is

Ziprasidone capsules, USP contains the active moiety, ziprasidone in the form of ziprasidone hydrochloride, USP salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents.

FDA label, Description section

Boxed warning

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )].

FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 5Labeled (related wording) 11Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 4Not in label — unassessed 13
What the badges mean

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,050 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Oculogyration21221.4
138.9–352.7ROR 221.6 · χ² 3,696 / p <1e-300
159.7 EB05 110.2 · IC025 +4.4
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Anosognosia108195.0
159.1–238.9ROR 196.2 · χ² 17,723 / p <1e-300
162.7 EB05 138.5 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious n=101 · ♀ 82% (drug 56%)not reported in cached trials
Blood prolactin abnormal115182.0
149.6–221.4ROR 183.2 · χ² 17,781 / p <1e-300
153.8 EB05 131.7 · IC025 +6.2
3/3 methods agree
Lab value / disease markerserious n=109 · ♀ 83% (drug 56%)not reported in cached trials
Antipsychotic drug level below therapeutic84164.7
131.2–206.9ROR 165.5 · χ² 11,854 / p <1e-300
140.1 EB05 116.7 · IC025 +5.9
3/3 methods agree
Lab value / disease markerserious n=78 · ♀ 0% (drug 56%) · 95% cliniciannot reported in cached trials
Abnormal palmar/plantar creases24162.9
106.3–249.5ROR 163.1 · χ² 3,252 / p <1e-300
128.8 EB05 91.1 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=23 · 95% cliniciannot reported in cached trials
Oppositional defiant disorder36118.7
84.3–167.2ROR 119.0 · χ² 3,712 / p <1e-300
102.3 EB05 77.2 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=30 · ♀ 0% (drug 56%) · 93% cliniciannot reported in cached trials
Electrocardiogram qt corrected interval prolonged67110.0
85.7–141.3ROR 110.4 · χ² 6,522 / p <1e-300
98.0 EB05 79.8 · IC025 +5.5
3/3 methods agree
Lab value / disease markerserious n=8not reported in cached trials
Spasmodic dysphonia23101.3
66.2–155.1ROR 101.5 · χ² 2,013 / p <1e-300
86.9 EB05 61.0 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=20not reported in cached trials
Schizophrenia, paranoid type2276.9
49.9–118.3ROR 76.9 · χ² 1,476 / p <1e-300
68.1 EB05 47.4 · IC025 +4.1
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=2not reported in cached trials
Schizoaffective disorder10776.0
62.5–92.3ROR 76.4 · χ² 7,368 / p <1e-300
70.6 EB05 60.0 · IC025 +5.4
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=52 · ♀ 6% (drug 56%) · 94% cliniciannot reported in cached trials
Malignant catatonia1363.4
36.3–110.8ROR 63.5 · χ² 700 / p 2e-154
55.6 EB05 34.6 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=13not reported in cached trials
Disinhibition8163.3
50.7–79.2ROR 63.6 · χ² 4,658 / p <1e-300
59.4 EB05 49.3 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious n=81 · ♀ 1% (drug 56%) · 95% cliniciannot reported in cached trials
Disturbance in social behaviour10253.9
44.2–65.7ROR 54.2 · χ² 5,013 / p <1e-300
51.1 EB05 43.3 · IC025 +5.0
3/3 methods agree
Reporting / coding artifactserious n=97 · ♀ 81% (drug 56%)not reported in cached trials
Choreoathetosis2749.0
33.4–72.1ROR 49.1 · χ² 1,174 / p 1e-257
45.7 EB05 33.0 · IC025 +4.0
3/3 methods agree
Labeled adverse reaction
exact term
serious n=22 · 91% cliniciannot reported in cached trials
Rapid eye movement sleep behaviour disorder1546.7
27.9–78.3ROR 46.8 · χ² 602 / p 2e-133
42.7 EB05 27.5 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=15not reported in cached trials
Obesity51239.7
36.4–43.3ROR 40.8 · χ² 18,654 / p <1e-300
38.4 EB05 35.7 · IC025 +5.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 37.9 · ♀ 21% (drug 56%)not reported in cached trials
Masked facies1339.1
22.5–67.9ROR 39.1 · χ² 430 / p 6e-96
36.0 EB05 22.4 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=3not reported in cached trials
Diabetic complication8038.5
30.9–48.1ROR 38.7 · χ² 2,797 / p <1e-300
37.1 EB05 30.7 · IC025 +4.6
3/3 methods agree
Reporting / coding artifactserious n=2not reported in cached trials
Neuroleptic malignant syndrome37038.4
34.7–42.6ROR 39.2 · χ² 13,037 / p <1e-300
37.2 EB05 34.1 · IC025 +5.0
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 50.6not reported in cached trials
Grandiosity1137.3
20.5–68.0ROR 37.3 · χ² 343 / p 9e-77
34.2 EB05 20.4 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=9not reported in cached trials
Akathisia (inner restlessness)36132.5
29.3–36.1ROR 33.2 · χ² 10,708 / p <1e-300
31.6 EB05 29.0 · IC025 +4.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 63.0 · ♀ 29% (drug 56%) · 92% clinicianNCT01053429: 80/3,391 (2.4%) on Ziprasidone
Oculogyric crisis5431.5
24.1–41.3ROR 31.6 · χ² 1,524 / p <1e-300
30.4 EB05 24.2 · IC025 +4.1
3/3 methods agree
Labeled adverse reaction
exact term
serious n=32NCT01053429: 1/3,391 (0.0%) on Ziprasidone
Type 2 diabetes mellitus85931.2
29.2–33.4ROR 32.8 · χ² 24,501 / p <1e-300
30.4 EB05 28.8 · IC025 +4.8
3/3 methods agree
Labeled — boxed warning
synonym match
serious PRR 4.4 · 93% cliniciannot reported in cached trials
Blunted affect1830.5
19.1–48.7ROR 30.5 · χ² 472 / p 5e-105
28.9 EB05 19.3 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=10NCT01053429: 1/3,391 (0.0%) on Ziprasidone
Tardive dyskinesia (persistent involuntary movements)70530.4
28.2–32.7ROR 31.6 · χ² 19,519 / p <1e-300
29.6 EB05 27.8 · IC025 +4.7
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 8.8not reported in cached trials
Homicidal ideation9528.6
23.3–35.0ROR 28.7 · χ² 2,442 / p <1e-300
27.8 EB05 23.4 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=32 · ♀ 0% (drug 56%) · 94% cliniciannot reported in cached trials
Blood prolactin increased11028.5
23.6–34.4ROR 28.7 · χ² 2,826 / p <1e-300
27.8 EB05 23.7 · IC025 +4.3
3/3 methods agree
Lab value / disease markerserious n=34 · ♀ 12% (drug 56%)not reported in cached trials
Dystonia44628.1
25.6–30.8ROR 28.8 · χ² 11,355 / p <1e-300
27.4 EB05 25.3 · IC025 +4.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 29.8NCT01053429: 14/3,391 (0.4%) on Ziprasidone
Hallucination, tactile1527.8
16.7–46.5ROR 27.9 · χ² 354 / p 4e-79
26.4 EB05 16.9 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=12not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Ziprasidone as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Drug ineffective (drug did not work)1,3711.2
1.2–1.3ROR 1.3 · χ² 71 / p 2e-17
1.2 EB05 1.2 · IC025 +0.2Reporting / coding artifactserious PRR 4.1NCT01053429: 2/3,391 (0.1%) on Ziprasidone
Weight increased (weight gain)1,1806.4
6.0–6.7ROR 6.8 · χ² 5,367 / p <1e-300
6.3 EB05 6.0 · IC025 +2.6
3/3 methods agree
Labeled — boxed warning
synonym match
serious PRR 7.6NCT01053429: 1/3,391 (0.0%) on Ziprasidone
Diabetes mellitus1,00315.9
14.9–16.9ROR 16.8 · χ² 13,837 / p <1e-300
15.7 EB05 14.9 · IC025 +3.9
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 2.7 · ♀ 77% (drug 56%)not reported in cached trials
Anxiety8793.7
3.5–3.9ROR 3.8 · χ² 1,746 / p <1e-300
3.7 EB05 3.5 · IC025 +1.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.8NCT01053429: 39/3,391 (1.2%) on Ziprasidone
Type 2 diabetes mellitus85931.2
29.2–33.4ROR 32.8 · χ² 24,501 / p <1e-300
30.4 EB05 28.8 · IC025 +4.8
3/3 methods agree
Labeled — boxed warning
synonym match
serious PRR 4.4 · 93% cliniciannot reported in cached trials
Insomnia (trouble sleeping)8043.6
3.4–3.9ROR 3.7 · χ² 1,535 / p <1e-300
3.6 EB05 3.4 · IC025 +1.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.1NCT01053429: 58/3,391 (1.7%) on Ziprasidone
Depression7894.1
3.9–4.4ROR 4.3 · χ² 1,894 / p <1e-300
4.1 EB05 3.9 · IC025 +1.9
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.9not reported in cached trials
Somnolence (drowsiness)7484.5
4.2–4.8ROR 4.6 · χ² 2,022 / p <1e-300
4.4 EB05 4.2 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.7NCT01053429: 72/3,391 (2.1%) on Ziprasidone
Tardive dyskinesia (persistent involuntary movements)70530.4
28.2–32.7ROR 31.6 · χ² 19,519 / p <1e-300
29.6 EB05 27.8 · IC025 +4.7
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 8.8not reported in cached trials
Tremor (shaking)6985.0
4.7–5.4ROR 5.2 · χ² 2,268 / p <1e-300
5.0 EB05 4.7 · IC025 +2.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.0NCT01053429: 12/3,391 (0.4%) on Ziprasidone
Nausea6791.0
1.0–1.1ROR 1.0 · χ² 1 / p 0.217
1.0 EB05 1.0 · IC025 -0.1
PRR-only: not supported by EBGM or IC
Labeled adverse reaction
exact term
serious PRR 0.6NCT01053429: 24/3,391 (0.7%) on Ziprasidone
Dizziness5921.4
1.3–1.5ROR 1.4 · χ² 76 / p 1e-18
1.4 EB05 1.3 · IC025 +0.4Labeled adverse reaction
exact term
serious PRR 1.0NCT01053429: 1/3,391 (0.0%) on Ziprasidone (serious AE)
Feeling abnormal5912.9
2.7–3.2ROR 3.0 · χ² 765 / p 1e-168
2.9 EB05 2.7 · IC025 +1.4
3/3 methods agree
Not in label — unassessedserious PRR 0.9 · ♀ 85% (drug 56%)not reported in cached trials

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Ziprasidone ↔ QT prolongation.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Ziprasidone?

In FDA FAERS, the most frequently co-reported reaction terms for Ziprasidone are weight increased, diabetes mellitus, anxiety, type 2 diabetes mellitus, insomnia, depression. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Ziprasidone have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )].

Do FAERS signals prove that Ziprasidone causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.